HALO - Earnings call transcript Q4 2017 | Halozyme Therapeutics, Inc.

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Operator

Good afternoon and welcome to the Halozyme Therapeutics Fourth Quarter 2017 Fiscal Results Conference Call. At this time, all participants are in a listen-only mode. A brief question-and-answer session will follow the formal presentation. [Operator Instructions] As a reminder, this conference call is being recorded. It is now my pleasure to introduce your host, Jim Mazzola, Vice President of Investor Relations at Halozyme. Mr. begin now may you your conference. Mazzola,

Jim Mazzola

Kerry. you, Good afternoon everyone. Thank

presentation today, Following and news slide call. we release close posted accompany with short results a our issued market this of a a to summary

can year provide halozyme.com. our the Chief an followed update at Executive Financial Chief overview a Officer You review Investors Dr. Helen President December our is Leading our both and quarter at call Chondros, of Stelzer, the for and for find Q&A. Demetrius Torley, page Halozyme’s Officer Officer, today Laurie and those who and on period. business; Medical will by join financial Q&A will Chief results our also will

statements. let Before statements. may the you results call, expressed The differ me materially during from forward-looking or that forward-looking Company's remind such we indicated by those actual we begin, conference in making will be

Securities with For Commission. risks, annual a description of filings refer to and and Exchange quarterly our the please

to me Helen. let Now, turn call the over

Helen Torley

good entered technology pillar Thank we pillar. in ENHANZE our Jim, on XXXX both delivered our during everyone. PEGPHXX results based momentum and and oncology the you, strong XXXX with afternoon We

Let the fourth filed me takeaways in with begin quarter. the key

converting a become signing XXXX. administration agreement Firstly, position the second new further technology XXXX, with ENHANZE the agreement. option in to of Squibb with Roche and as partnership Bristol-Myers agreement reinforced December of with This with was therapeutics has Alexion, our go-to a for the in signing the in IV subcutaneous established collaboration of our the expansion

for XXXX some number in to I’ll XXXX in progression-free meet business strong the of include million than provide enzyme expansion with model continue with X we oncology enabled ENHANZE, same us leading in was ENHANZE most companies registration wherein significant two Starting our HALO-XXX, finally, XXXX. cash Squibb XXXX in licensed record Secondly, and with XX% royalties inflection as eight XXX ENHANZE pillar, for grew These company each a regulatory patients we late we of our recently our additional target accomplishments we detail. several at like of on fronts. the more pillar. to now review begin history. color and critical over And achieve these on agreements. XXXX, project, rHuPHXX clinical slide of product achievement the In United I payments in program, and events progress to $XXX takeaways, greater clinical be to achieved and million first those will adding milestone Halozyme. advance survival strategic year today, our study a our Bristol-Myers on QX, signing position one Phase to and would we our we sites entering accomplishments screening product in on approval continues States, Alexion. PEGPHXX QX upfront enrolment ENHANZE transformative strength the milestone $XXX of With X, for study in one new

a represented ENHANZE to-date approval US of in and XXX and US regulatory ENHANZE. XXX% HYCELA Firstly, approval. June year event a last is significant with EU FDA record second a gaining the maintained FDA high RITUXAN approval submissions for of It product

Bristol-Myers collaboration XXXX. fourth With quarter and X studies the data, following of signed of Perjeta respectively in clinical testing Squibb two Secondly, approval we data Roche Janssen and HYCELA RITUXAN Darzalex SC multiple SC of their Alexion. are made year of and with the proceeding pleased partners agreements combination substantial X in to study. initiated we of the that generating new thirdly, support And and progress our corporate Herceptin FDA Phase last Phase with this two Janssen SC

target. our longstanding expanded we addition, In agreement for additional existing Roche with

being is analysts of and products, ENHANZE that which exceed billion the to as world’s by $XX Opdivo Darzalex $X pleased developed very in is such and respectively projected are leading with Bristol-Myers’ peak sales. billion Janssen’s some We annual

As single-digit on the we based currently the sales, ENHANZE that with approved product mid XXXX. average ENHANZE revenue products royalty slide royalty receiving project achieve approximately target from that illustrated our a net with on to X, in ENHANZE on billion and the development potential existing planned agreements, new on Halozyme has $X

the on degree As number always, these will geographies launched sales portion approved, penetration of subcutaneous indications overtime. a of depend the actual market of and

goals of specifically, Turning key partners our slide support targets. advance in focus have the towards is X, to our we ENHANZE More advancement the XXXX to now target commercialization. for two to their

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were to in XXXX. and initiated in The continue SC. studies Darzalex X XXXX quest first is Phase

and with dexamethasone, patients, following trials. infusion. SC multi-hour Janssen the IV reaction myeloma, the Myeloma. Darzalex a now value lower multiple formulation to combination less. take evaluating the four be potential myeloma for secondly ENHANZE just me SC in them of shared Of was trials in a ml for we population. SC XX evaluating These data and at are when infusion SC Last may moment of Relapsed clinical allowed to which finalize or plan the delivered studying note, ASH, compared are registration to refractory Darzalex Phase additional bring injection current to able ENHANZE five where minutes pomalidomide development Janssen Let to in or rate a related reported be December Smoldering outline DARZALEX is Halozyme. amyloidosis to their and X with

six Phase Janssen clearly and Darzalex to or commited planning refractory With plan diagnosed is myeloma plans and Darzalex refractory program with to combination treatment burden patients. the In multiple for various Phase Japan, SC the reduce addition, of studies, SC its relapsed newly patients. with development X a a myeloma study for initiated of Janssen X and a patients Phase study has four a in ongoing multiple in in Darzalex is X SC, potential therapies, for including relapsed studies or

we by start The study this [ph] in later SC. combination confirmed enabled of is the with advance Based product and Herceptin Breast second SC program, dose [HER] combination results, clinical fixed the initiate dose formulation and combination the in of expect Phase Antonio XXXX for study XXXX, to using IV development has Herceptin on and enhance of Symposium, X the approval Perjeta fixed-dose plans shared SC combination FDA a Phase the enhance San our fixed of cancer, Perjeta X year. adjuvant Cancer breast the SC Roche Perjeta/Herceptin of recent the to Phase X to at

United per studies, Squibb's Lilly's Phase in enabled products our and progress addition new projected to of for On Opdivo. X a care. partnerships, and are with the be of a may made once exists focus close Alexion. once to year, separate the to In interval are ALXXXXX, have from the new Roche the an with December Phase infusion focus new product on to still the of expected FDA two XXXX products good collaborations many in in following supporting its of turning most strong noted testing our by with many making current patient we Alexion that a this experiencing And finally, parallel, in SC programs delighted initiate hospitals benefit project in seek that benefit Roche. expanding treatment enter clinic. partners With moving call, technology. of will partners or to dosing month. study believe the ENHANZE, To our last signing every into startup Alexion's available Roche to targets to strong due In year. Roche collaboration the those capacity XXXX. to in June and in our the clinical with is the delivering that signs ENHANZE we already the the is has other eight X two weeks, four and on additional formulation the investigational continue progress further RITUXAN or our Phase Bristol-Myers unlocking to we through constrains, ALXXXXX be X agreement in unnamed in time, activities centers, subcutaneous both And target recent we target. are the earnings of States, following value ENHANZE, duration and by is goal approval for our to

vasculature. maximize I HA, to Drug certain partners to Our opportunities and turn ENHANZE. and will color that is on of we the that strict our roll-in tumors investigational temporarily around pipeline quality degrades the pursue of therapy, can remains targeted HALO a PEGPHXX. value active discussed PEGPHXX tumor and robust or cumulates continue now

pleased from I predict results to XXXX. am Oncology were cancer high cancer global companion share a patients with peer study PEGPHXX Ventana billion approximately an of X metastatic reviewed December with partner and potential and $X first-line our Journal in published alone. HA studying HALO developed are of and pancreas XXX with pancreas that in identify our We Clinical diagnostic, to tumors opportunity Phase

of pancreatic our we and an evaluating in X. line study enrollment. Slide cancer endpoint overview study interim the progression to survival for patients. interest Turning resulting combination achieve in continued be the an of analysis with first in when free primary in Investigator number target with strong There’s gemcitabine conducted remains will Recall PEGPHXX ABRAXANE progress X our Phase events. first

project from use continue examining quarter Kettering has in We conducted Yu's grade the gemcitabine. included Dr. Center achieved low-molecular-weight anticoagulants, will HA of data in X injection of in ongoing XX HALO-XXX of Part no shows PFS of results oral events with of status. with heparin. thromboembolism. or a And the as today Cancer his backbone of heparin study HALO-XXX patients late investigator events reported combination number an daily low-molecular-weight of The fourth target Yu trail Dr. rivaroxaban HALO-XXX, Memorial of sponsored reported Recently XXXX. conducted PEGPHXX irrespective at X trial the to the of patients, injection. cases place Kenneth same ABRAXANE at grade chemotherapy receive been and [ph] Sloan be study,

against rate the this best overall with regulatory underway and to addition, in study the a evaluation population. of the future is patients, by labeling analysis PEGPHXX. rate high determine the now response In event Dr. and HA response an a for HA of use in XX% against conducting retrospect all-comer to feasibility to status rivaroxaban Yu's evaluate patient showed

PEGPHXX this update our from inhibitors, clinical cancer negative cohort, to patients progress able Beginning progress assess KEYTRUDA now in provide slide we’ll and X, to checkpoint in second of positive pembrolizumab I'd on of types. our with enrolment plus are XXXX. Turning share we non-small to trial and response Pending the studying rate patients. PEGPHXX like and an continued in combination or tumor potential data in be in other development cell PD-LX gastric project lung study number sufficient tumor a we the of half to with

timeline clinical We’ve a a we've our total making in of data. XX collaboration and clinical with of and In we PEGPHXX the to portion Roche of encouraging studies, further data strong potential And made response study call significant of the gallbladder over PEGPHXX in tumors make to to and high cancer. examining away in the Laurie? I’d our for a of months with results HA is gastric dose this to our were and studies Moving to Closing closed financial the just focus The evaluating, detail. January Initial not has from cleared end clinical initiated collection progress Xb start our in Success pancreatic Phase a several good with events, to all with portion analysis study XXXX. projected presentation opportunity. greater with is and in Laurie and in decision the cholangiocarcinoma indication finding portfolio collaboration like and atezolizumab additional proceed this that plus with has represents the to continuing cancer investigator pan-tumor successfully with pancreas patients our cancer, at on for multiple de-risking at report was the Forum are cancer, only opportunity the XXXX cleaning enrollment submit developments year. Scientific discuss continue PEGPHXX, PEGPHXX data enrolled. of in eribulin. tumors. [indiscernible] to of of this representing to large turn we're patients data beginning other the progress And now maybe pancreatic evaluate in fully of cancer the study, Halozyme and the planned to

Laurie Stelzer

period $XX Thank on driven of of upfront prior totaled Both million from million, X by see million revenue million you, and payment payments $XXX.X $X.X where will totaled product you you Bristol-Myers from will the the totaled $XXX.X million, year the in Helen. fourth million upfront an Royalty XX% compared of Squibb which revenue to Slide and that I will and includes $XX.X $X.X million revenue million of BMS totaled revenue see HYLENEX collaboration for the quarter begin was a for payment the other that XXXX. increase upfront from from rHuPHXX fourth Alexion. sales of quarter $XX sales $XXX.X Alexion. the recognition

the to XXXX. for million or to quarter compared in loss for including $XX.X fourth of to product general and prior of from was share fourth flat development million and at management XXXX as $X.XX marketable share due the slide or Net income for also of guidance sales now million to as I net P&L. fourth was XXXX. year quarter or the per slide a operating a at income December after in loss personal detailed million per due for from provided Revenue to per with XXXX totaled ended $XX.X period. million X a or $X.XX $X.XX the to we at quarter of $XX.X breakdown compared $XX.X move expenses of our $XXX.X $XXX.X would we $XX $XXX.X year to $XXX.X XXXX. XXXX the the the from year were to more expenses December for Net a the guidance compared primarily million and performance administrative full unchanged million securities full Cash, equivalents is a quarter expense the disciplined The compared million, expenses Research the Turning increase increase to XXXX. million, period. the XX, XXXX compensation year was per XXXX. share. million cash financial on million, were was to noteworthy quarter stock-based our which $X.XX for shown expenses XXXX compared like our were increase $XXX.X $X X. $X.X X% Selling, $XXX of million was which Cost slide million to the million was net of on shown share in $XXX start for for of of in the XX XXXX. XX, quarter on

the to does expect which full of the $XXX ENHANZE year net potential deals. XXXX, to new for we For revenue million continue million $XXX not include

manufacturing anticipate growth Within by decline growth as HYCELA. partners royalty orders the line, we their XX% which to sufficient our of project API forecasting API FDA the low XXXX, product until we changes are XX% we in to from and plans have have revenue largely RITUXAN partners driven manufacturing Offsetting approval a safety of API royalty currently and Recall in remain support partners shared this as we and our will complete near-term is XXXX. stock expected transition. gain orders

to principal $XX flat to of of repayment burn million, million $XX $XXX Operating to of royalty-backed to XXXX take includes We million, and XXXX continue $XX million end approximately to million debt and us interest Oxford expenses which for expect loans both $XXX year cash related XXXX. balance XXXX. and operating cash we our which million to SVB, $XXX million and $XXX will project of into payments

XXXX, we of January our the it adoption Finally, statements we difference royalty due for share timing new have I current receive the in close quarter record for arrears, between guidance, in the to financial to payment royalty will additional recognition reporting impact one the to and payments applies QX upcoming period. actual an difference details our the Historically, FASB revenue in our be like the reflect revenue following estimate as partners. will and we XXX around the in recognized our we to royalty between subsequent recording quarter starting and from financial revenue would when the revenue. Under Topic estimate how

me the revenue have this sales. of $XX.X in sequential Helen, of of royalties million quarter a our resulted the For XXXX, provide would QX to this that, from closing call reference, comments. partner approach royalty who million let a on based turn $XX.X in will With $X.X back QX applying reported increase

Helen Torley

entered a for Laurie, momentum. year strong in Halozyme with summary, XXXX XXXX Thank you we was transformative and

will entered initiated million in cash. strongest including with four and X our year Phase to ENHANZE deliver position SC In studies of X we with and initiate approved pillar, this quarter year Roche [ph] of Phase highlights to company's with pillar great to to continue study strong finally We've XX% in oncology projected and Specifically, XXXX the PFS recently project our of X we planning the for ENHANZE. of DMS growth. study paving a X another history initiate products in of with $XXX year. cash Halo-XXX and got DARZALEX Janssen’s Roche and and XX% currently Phase plans the later our momentum Alexion in target Herceptin events make studies, robust number include progress ongoing SC, planning fourth study studies six to marketed our Phase Perjeta the and our royalty this

based the hard partners. we're both patients. and my to have ongoing near in and our to And by two long-term making in work for gratitude advance we studies investments of to second on support progress, programs Above value and the with team close for remain talented confident Halozyme generate as data continued we and want our appreciation ever, in and pillars to from our all, our patients, strategy continued that response the shareholders pan-tumor I expressing their addition, will In partners potential of rate of year. half the report

would call. Operator, please calls. ready now open take are your you We to the

Operator

Our from Peters with Bank. Instructions] Andrew question you be will Deutsche Thank [Operator first

Andrew Peters

my all taking congrats for progress. the questions and thanks on Hi,

Then that billion you wanted royalty that number think about outlook. break about, on biggest of the if you kind biggest are the you how drivers components to assumptions. of Just does the of that think those a upside sense revising about number, factor areas potential talked the if more can you potential ruble kind ENHANZE decision. When collaborations? out dollar downwards or get you've upwards continue to you to little live study, the profile into you. And a just new the or a Eisai question Can the failed just as for on into of target Thank that you was that what outlook, as book that. of there and bit to number up And mind to you learned on the around from data decision? and portfolio then as a color the enhanced went provide to there in and

Helen Torley

Great. Thanks Andrew.

what’s ENHANZE marketed there, billion which point Opdivo, you to products inflection curve, but that anticipated $X the is launch first chart products with based in that's have making of me where see inflection of growth royalties a the ENHANZE the our there where the XXXX. nice key continued terms there growth products and driving near-term the time revenue on projection have presentation already I our the in nice question sales can pattern of getting and and you the DARZALEX coming we Let really see is, have there see projections step growth address a that potential is then and is towards we the where you think substantial including, by point an where like really we from project then period analysts on in

in from what's in we XXXX Andrew know based that, Now that a current anticipate start on that we good chart partners. a you steady raised our just included plans point, in that

potential XXXX. new the does exciting for this and products XXXX not in start So of include

clinic. to And targets based additional upside see entering so this, do the we on for potential the

got our evaluation additional them, just, So question. the the PEGPHXX we had with make the that taken final this from say in didn't from study Eisai let been Eisai cut portfolio our to a and Halaven decision me did The study not counterparts, there can before, with data and get any proceeding them feedback the was I evaluation. We that was turn that was seen. color, with

been profile to I fully a really was go believe the assessed a which nor their in no portfolio part. this be go has there by target specific final So Eisai, decision data was

Operator

question next Goldman Dana Your is from Sachs. Flanders from

Dana Flanders

on maybe here, reengage think follow-up the haven't ability you My very you for How the on from should longer to towards a a and questions. maybe where innovator. thank maybe we activity Hi, the forward seen your one ENHANZE. have go of couple first using we just I dated just push as platform about know them much partnerships basis? much ENHANZE

Helen Torley

of the the it’s at isn't partners teams left portfolio ENHANZE sometimes question, our your their is a go they with partners to or contemplate priority, want a in differentiated. by team standing thanks time, and a this basis could of ideas question generally stone their where to become alliance competitive regular is This not no there and longer plans Yeah, to in do and going for there subcutaneously our forward is Dana. and this subcutaneously unturned is part moment to bring products product, something their portfolio more but sometimes on their development help

Dana Flanders

And quick in the QX. that the QX that reiterated here, great. expect the I in by sorry my know XXXX? see data you early study interim could Okay, QX you -- come or actually data We by follow-up

Helen Torley

achieve target the we is that asking data anticipate late because will Yeah. what events start clarifying the will te final in Thanks analysis. number and data that we that fourth question cleaning for quarter, PFS of

in absolutely will the So be data right, actual the you're to XXXX. DMC available

Operator

Piper with Our Duncan comes next Jaffray. from question Charles

Sarah Weber

on Sarah is This Hi. for Charles.

to may Perjeta of believe stage should this Phase cycle? is at X BMS [ph]combo couple what of Herceptin, can you to you also on this look some the color fixed why you updates remind its provide a Just for choosing to And we be Can year? ENHANZE. on questions Roche move us on collaboration then

Helen Torley

is But if discussions collaboration, identifying point targets can’t portfolio we additional testing their will entire steps Sarah. public up are that in you, for year. BMS SC to is year XX be signed move Herceptin thing the BMS is in With presented you data the Thank firm earlier know study they this At as that and last to the the I all the we any the Perjeta, start taken. Yes, agreement was with Opdivo list Roche this XXXX. plan potential Opdivo with time, recent believe operating this only what with that from and of but the the FDA show forward that motivation last the for patients. in certainly that IV benefit will on formulations. did support clinical would on be say Roche I the the into And the for at from

If you think about a these patients, they tend cancer to be therapy on moving time. well with for their long

ability subcu patients get is that centers. having So think life fixed what wanting dose much these up is their to free patients back are I single who to mind or easier from imagine IVs, by to being injection, for in hospitals the about for Roche’s just is how get filled infusion not a to centers everyday that and in seeking infusion

Sarah Weber

Great, thank you. And just one follow-up.

and second anything enrollment the for picked though as the why it enrollment rate driving the should combo about first KEYTRUDA, then color Any Phase that’s of think during study has data X somewhat. beyond half? case sounds with we PEGPHXX So timelines, been that

Helen Torley

on ask Alright, comment me Demetrius let to that.

Demetrius Chondros

Helen. Sure. Thank you much, very

that year. So in trajectory, a half our the approximately second study that of XX last to with enrolled it update data and in KEYTRUDA end to of our enrollment initial at enrollment current recall the by with our we last position continues is, said this in study, if be of we want patients the year reach share response in

get going is very our particularly according and So anticipation, cohorts going to very well it’s overall well.

Operator

from Jason question Butler next with Your Securities. be JMP will

Jason Butler

question. Hi. taking Thanks for the

on one of specifics data readout around Just should cetera? terms the another the et that we patient of about the biomarkers are, on combo what in expect study. and current duration what your can KEYTRUDA median Based PEGPHXX population, you plans therapy from talk

Helen Torley

me Yes let ask address. Demetrius to

ask I PDL-X think comment and growing but quite be what rate duration really might useful about and the positive response to Demetrius in we’re X. on some it’s looking therapy negative to of give the think at

Demetrius Chondros

Sure.

in negative, of as rolling The all-comers as most subgroups analyzing that historical the them is, as the enrolling to cohorts well to cohorts available PD-LX study retrospectively. -- both data recall, So status cancer, lung data cohorts. PD-LX look to and overall analyze recent response cohorts as into specific know, the you compare we're for study two disease the the both whether cancer, gastric as PD-LX well population we and really you the positive would Keytruda is PD-LX objective a in and

Helen Torley

we in can therapy that the certainly is we get perhaps of from that. couple you later might, might It patients, seen studies. recollection, we back you of my of Jason on exact Duration the expect, a we but have Keytruda cycles, three line to range in we'll long get the information.

Jason Butler

Great, then royalty change I on just had in a the follow-up and revenue recognition.

two kind reflected a this period? same real Sorry, where quarter if from to changed being are be quarters in missed to, have you I reporting is true up, reporting this but, some from you lag of that as a time estimate, the there to going

Laurie Stelzer

Laurie. and the to it from the for earnings actually, our Hi, way partners. the Jason rule to go sales, the quarter play retained will book retained to QX No, so quarter royalties royalties book fourth to be QX, it'll as won't quarter sales that there it out its in we’ll sales quarter going is a one in up, relates Fourth earnings. we go only will doubling

Operator

question Wang Gina Our be with Barclays. next will from

Gina Wang

my you Thank questions. for taking

technology the Can remind enhanced Just X Can timeline you one platform. question, use royalty. time for the starts? you it from the Phase general readout quick regarding us,

Helen Torley

five from first human long-term be we is to heuristic it approval. to in about tends usually The give, Thanks. years

Phase we the study number the to the But the get to a get perhaps X a of dependent what tended of see be get on the of half very X So the Phase enrollments. through is a on obviously study then design end the and of the approval. to duration will a actual testing file and X and year the point year studied endpoint year FDA, year and for enrollment, to with to time agree to being Phase

in asking specifically, commented So very XXXX the that again Darzalex, for overall. be the is that as there launching I is question example, for timeframe year five if expectation with the consistent which on will timeframe, you're

Gina Wang

Thank you.

ASCO I these gemcitabine the profile FOLFIRINOX learn with question from efficacy oncology can know data, Another they're versus for the you GI combined so anything about programs? ABRAXANE, different data PEGPHXX. for PEGPHXX, the other when the

Helen Torley

that for question. Thanks

FOLFIRINOX What from to studying, with is great the for chemotherapy bring to limited a learned and You dose up point. poor dose we small that to able different ability combined that data which is patients the saw all. when FOLFIRINOX. PEG be agents, a is referring or tolerability four we at

important about that that, us particular combination. so that an for finding was And

we're we very thoughts were challenges have ever our gemcitabine a tolerability if patients So problems. contemplate able record X we to will track strong which XXX with those it. We chemo forward in Phase going see having we’ve them, issues excited being similar ABRAXANE didn’t we patients overall Obviously one study. studied of where combination, dosing particularly our take with combination a got of or gone tolerate to multiple are

So, it some information program certainly our XXX. but did give impact registration no us on FOLFIRINOX about

Gina Wang

use last like It have drugs and been of you low-molecular-weight seems regarding different heparin. Thank question several the tested.

have the treatment prophylactic risk? you thoughts or oral thrombotic forward, Going regarding for any do for IV version

Helen Torley

is the showed and events. oral this XX thrombotic results actually no the inhibitor PEGPHXX X for study events. by gemcitabine IST his CE or the Xa and one He quite prevention patients, with year initial Hugh of reported Yes. he doing We rivaroxaban studied grade his earlier a data at were from ABRAXANE Dr. factor encouraged of of using X anticoagulant where

to evaluate continue And PEGPHXX study what there would anticoagulant for with step and would oral gain but patients, the to rivaroxaban. to more to be next is path what be the our the so feasibility labeling also

work a that do more be path identify bit need what is. to we to the for So

Operator

will with Your from Citigroup. next be Joel question Beatty

Joel Beatty

the for questions. taking thanks Hi,

early programs, The seen over DARZALEX be data then then on X X underway get we’ve and that we little to question as PKPD Phase to Xs XXXX? is the on and products potential for on to first you second those shorten is are Phase over bit And go such in have as additional decision will a PEGPHXX we'll relying related studies? of being approved the the there opposed if as the time, is what possible the enhanced outcomes from Phase announced more additional larger

Helen Torley

DARZALEX I’ll PEGPHXX question. right. question the All and will Demetrius address the take

the of very bridging and For a HYCELA pathway, included the DARZALEX, there good safety a difference not shows which in data with RITUXAN out the that or that up because then FDA approval you was laid generation a PK point efficacy. the bring

and the So multiple themselves. that generate their I at look development is the asking Janssen myeloma later DARZALEX as is with to choosing are mono-therapy plus then tend be like drug be because therapy for a Where are data of of second a different question do patients the doing life think taking available DARZALEX, combinations pomalidomide. certainly to using to companies they is will do plans ENHANZE that population

talk do may know terms so And data, to of and lesser that certainly wanting be so question, great very that efficacy of with I is companies FDA generate to they over physicians Joel and with but able time, think it respect are all studies. in the with those safety possible combinations, and

Demetrius Chondros

Sure.

look survival of benefit overall the PFS work provide based the well outlined end analysis analysis. and the this and the until and that PFS. So overall trigger over at of a at final by data of towards Data will study. expect events final Monitoring They make for the analysis as at on number independent an and conducted filing will and as that the on the safety the as risk Committee outcome they to do based interim interim look the they will will include analysis recommendation final year obviously PFS be study will the occur the continuing we Helen assessment interim the And the they assessments we or will

Operator

Jessica question from will be JPMorgan. Fye with Our next

Jessica Fye

investors Thanks PEGPHXX. seems my taking we on for the like question. for speak and most pillar Great. It use on stock have mixed more ENHANZE the

not the the R&D kind you activities? Phase if ratio XXXX much sub investing study PFS OS, So stop are alone X of of product? spend hit at have R&D is other X that optimal dollars you versus behind And or the Phase would does study how targeting R&D

Helen Torley

we’ve is some investors some year for and I event great PEGPHXX bit a address or hesitation upside what of enthusiasm way for only in cancer meaningful because question would that. be we you been I to more upside a a we reflecting company that cancer is the is ENHANZE I believe product pancreas have with to do enthusiasm of PEGPHXX or an it, stock the has a expense are ask look recognize become the so most think that have about a platform. last will likely there then have possibility We Certainly what product Thanks then you if other for is pancreas developed like, that saying the Laurie does that scenario a little But but And are not patients. on We would pillar. hear investment. the a the people is de-risked to company Jessica. if the pancreatic the huge do and in ENHANZE the in for saying PEGPHXX successful then cancers not the

Laurie Stelzer

Sure. Hi, Jess.

is spend and vast on the XX% our As of our R&D you majority line spend is our know ENHANZE of on PEG PEGPHXX. about versus

question the break the does. near or that X X I X, Your don’t they don’t majority is Phase X spend our cash say specifically around our really we But study, of what can on is have out. the Phase smaller that burn cost study plus X, Phase Phase that the that

Phase without So the number, majority that of the giving spend exact X. is just PEG on

Operator

Wells will Our next Jim from with be Birchenough Fargo. question

Jim Birchenough

progress. on congrats Hey, and question guys. for the taking Thanks

launch wondering reimbursement follow the Just HYCELA a of you the up. how be may for MabThera willing the might in in saw Europe And might as seeing I differences to first you in with US trajectory what characterize guide Thanks. have be impact couple a versus RITUXAN are to you adoption? if

Helen Torley

do not formulary, can which updates made So with I from they’ve don't kind comparing that what in making US heard the provided was The getting about and strong the the were But on specifically marketplace to share Roche from less Roche orders, this this healthcare includes Roche everything RITUXAN know was can’t so all can numeric updates be infusion that, but specifics the particular say. we’ve HYCELA can you have that no EU. updated give those be both or patients the will the that getting comments, pleased about the for US with and systems any we well overcrowded, US patients hospital the the of has we we Roche we for many IT in time working the progress about anticipating has we on value comments But from steps. by expect think proposition that they specific proposition so data can providers, time. at the when value are mean the through received that in spending by remains of some we centers any and think of they made

Jim Birchenough

process just consummating Yes, of additional particular you've of a accelerating you areas great are terms in Maybe deals on. the getting for the deal, expect deals these bit deals, pace and we each should in and in talk on focused deals? are you're and the XXXX additional about had that success in there economics

Helen Torley

in that any is it ENHANZE some of can therapeutic beauty with The work area. products

want large Specifically they they a have or subcutaneously. get looking large get that molecules infused companies a volume are infused to

at working look in in towards deals available some time our have control a a that, when to are can We number of regard we With specifically in we're interesting to is companies and signed I certainly with this try very So Jim. discussion say what we what XXXX. molecules areas. therapeutic not is in active as are exactly of broad deal another

benefit So, the platform. more of would that deals. but what find from there will ENHANZE out are coming because I we is XXXX, sign we'll don't I in deals more there we know a are see ENHANZE them best, try our will if will molecules lot continue to

Unidentified Analyst

for final the maybe it know, to individual to ID, in one might just harder Roche have each whether be each just is the compared component co-formulated but you PERJETA be co-formulated to be or compared answer, evaluating combination the combinations. It then individual brand herceptin really and component will current will And both question. to combination

Helen Torley

study study out a and Phase X all talking the Phase did determine what San reported them allows was The you're at about, into X would dose Antonio fixed what exactly that those with combination. taken breast be to

a Phase what Roche questions to Phase I talk so that have the take goal possibly study. or design answer was the whole know fix X the dose but X of specifically So is about to that, would I allow Phase not their do posted be, single discussed yet X would to can't into them

Jim Birchenough

signing on prior how development you clinical if you we herceptin products approval. see do program subcu a how we've final, from time product on trying nice seen similar development, sort based a to moving have to look of one gave just at, what could a clinical sorry, And a of to into from previously on development like move benchmark a you in quickly development final, Opdivo deal metric quickly get to metric map these Do with Sarah? based things

Helen Torley

Yeah.

nine entry that that. able and is would product as well, company future at to good we as be a has hope on clinic is, eight months did the to entering look DARZALEX want to focused a to that I priority that from think the the of if with to of got range is in good, was target clinic DARZALEX, signing you that achieve would and certainly be a

in start terms. So, I those you think can thinking

Operator

you. Thank

Our next Lee from [ph]. Orlando question will be

Unidentified Analyst

the additional might Hi visibility clinic understand have what guys, questions couple us these maybe taking on on thanks when on for questions my Can a be? progress. we might that of or products are you I and maybe additional congratulations the entering ENHANZE. clarity help get

Helen Torley

because point time. are to not of including companies this challenge, a variety make choosing reasons owner competitive in of a variety It's public the them reasons, obviously, for at

statements confidentiality the statements, that the So, agreement, our in with partners made. line public only of are it’s part have make

can’t give you I a when timing, they So would do haven't that. they because indicated

that about sorry Orlando [ph]. I’m So

Unidentified Analyst

like few the about provide of on last something it talk these maybe some maybe Can to for inbound has then out you you’ve or few Alexion came additional where information gone had how deals was they more example to an inquiry? deals that about quiet maybe done. And the of that you or have couple on. things of that going on okay. - been There That’s a last been

Helen Torley

Yeah.

or platform on I the at another. one think started last with every since company we years XX Over have we working just the about point met

there’s people assessing your doing years competitiveness and two way. last we've companies wat think believe familiarity, this portfolio a help we been in over to I the recently background So going of is degree good could or ENHANZE three more saying

people done And this this, about of bit say, the in team so business it’s help some a we a up have are a way. think can other times the analysis been pull, push thinking because we us and and and you with they we've go say, of and those, phone and development little hey, familiar portfolio of

is approval. a from Alexion spoken company So work on we for Alexion and obviously moving the very that to we the Baxalta a with but to the HYQVIA many leadership years, team very over John process. have dynamic Ludwig very was helpful because closely it’s team

in a the in both they it’s December. think signing that obviously helps very of So we came for with deal but through I when enthusiasm great and familiarity think dialogue, for very platform, ways. active a that the have speak But it goes frankly and

Unidentified Analyst

discussions I'm talk what a are Yu's we to your going the to is pancreatic in Phase ongoing and data how other docs bit on little X, within additional wondering now how the doctors? prophylaxis color talking Thanks from the the docs for paper was then able be about much. GI Thanks. forward Dr. on PEGPHXX, and you place ASCO saw maybe might And and lastly Great. very

Helen Torley

X that's Yeah. PEGPHXX but to to and for heparin we’re rivaroxaban that. our the look ease heparin, low Obviously, commercialize the molecular Phase came and looking at to Thanks constantly plan for in study, with using low patients molecular we’re desire where in. burden we

update I reported intrigued. on small we label patients to were get there’s enthusiasm lot that and recognize a us their far, that but would [indiscernible] doctors based to of feedback for to and label that still these of gave update us patients so it well. a take to So getting what a continue as identify number the and They evaluate they pathways a for XX think

pathway. a well us patients easier very is low would explore just the be heparin there are is they continue for doctors think I burden molecular using very for on support to can, So little accepted, so focused wherever to it that patients,

Unidentified Analyst

much. you it. Got very Thank

Helen Torley

Thanks, more any Orlando. there Operator, questions? are

Operator

for back it comments. I'll over turn to you closing

Helen Torley

forward That’s thank and look evening. us We joining begin Thank XXXX our speaking give to with great. on you with you are and call. you Well great really and an great next to today. you we excited have momentum such for everyone update a

Operator

teleconference. today’s gentlemen, and this Ladies concludes

You may disconnect. now

Halozyme Therapeutics (HALO) 21 Feb 182017 Q4 Earnings call transcript